FDA Adds Poison Warning to Fluoride Toothpaste

Last month, as 8-year-old Molly Statt stood in the bathroom brushing her teeth, something on the back of the large-size tube of Crest caught her attention. She stopped brushing.

Looking up at her father standing beside her, she motioned to the toothpaste and asked, “Is this poison?”

“Of course not,” Paul Statt reassured his daughter.

“Then why does it say ‘poison’ on it?” she asked.

Statt looked closer at the label on the back of tube. In small print were warnings he hadn’t noticed before, including one that read: “If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately.”

Caught off guard, he didn’t have a good answer for Molly. For a week or so afterward, she didn’t want to brush with toothpaste. Now she is back to using it, but Statt worries that she’s confused about the safety of toothpaste and about the truth of poison labels. “When did they start putting a poison warning on toothpaste tubes?” he asks.

Like most people, the Petersborough, N.H., resident assumed that an over-the-counter health care product like toothpaste, which we are encouraged to put in our mouths “at least twice daily,” must certainly be as safe as the water we drink. But it’s not. And that’s the message of the new warning labels required by the Food and Drug Administration on all fluoride toothpastes and dental care products shipped as of April 7.

None of the caveats that began appearing on toothpaste tubes in 1991 so candidly broached the risks of ingesting too much fluoride. General warnings on toothpaste products that display the American Dental Association seal of approval heretofore cautioned: “Don’t Swallow — Use only a pea-sized amount for children under six,” and “Children under 6 should be supervised while brushing with any toothpaste to prevent swallowing.” The word “poison” wasn’t used.

“When I receive the fluoride here, it has a skull-and-bones on it,” Regina Miskewitz says of containers of the chemical at the Princeton, N.J., laboratories of Church & Dwight Co. Inc., maker of Arm & Hammer products, where she is director of research and development for oral and personal care.

“If a child was to take a big spoonful of this fluoride, I don’t think he could swallow it,” she says, “but if he did get it down, it is a poison and the child could die. If a child ingested a whole tube of toothpaste, he should be taken right to the emergency room and he would either get his stomach pumped or get some kind of antidote.”

Three ingredients found in most toothpastes pose health risks if too much is ingested, according to Miskewitz. Sorbitol, a liquid that keeps toothpaste from drying out, is a laxative that could cause diarrhea in children. Sodium lauryl sulfate, an ingredient that makes toothpaste foam, can also be a diarrheic. But the fluoride poses the most danger if too much toothpaste is swallowed — particularly to younger children.

“Small amounts of this material go a long way in causing disruption in their bodies because they are so small,” Miskewitz says. “The fluoride in toothpaste is considered a drug. Even though it is an over-the-counter drug, we are altering the body when we brush our teeth with a fluoride toothpaste or tooth gel. . . . As normal consumers, you’re not aware of these things. But I’m sure our 800 number is going to get more calls as products with the new warnings show up on store shelves.”

This summer, as toothpaste shipments with the new labeling replace older inventories, consumers will see nearly twice the warnings displayed on the back of tubes and cartons — the ADA’s general warnings along with the new FDA-required statement that starts with: “Keep out of the reach of children under 6 years of age.”

Research has shown that because they aren’t yet in control of their swallowing reflex, children 4 to 6 years old typically swallow toothpaste when brushing. “That’s why it’s recommended that kids get only a pea-size amount of toothpaste,” says Miskewitz, “because most of that goes down their throats.”

A 1995 study at the Medical College of Georgia School of Dentistry found that about half the children this age don’t spit out or rinse out — they swallow the toothpaste instead. Making matters worse, they tend to use too much toothpaste on their own — especially when they use flavored children’s toothpastes.

While the cavity-preventing effectiveness of fluoride has been demonstrated, too much fluoride not only can be dangerous, it can cause a condition known as fluorosis that discolors or spots developing teeth. Research conducted by the School of Dental Medicine at the University of Connecticut Health Center concluded that brushing with more than a pea-size amount of toothpaste more than once daily contributed to most of the fluorosis cases it observed in young children. In areas where the drinking water contains fluoride, children who swallow even the pea-size amount of toothpaste are getting too much fluoride and are at risk for fluorosis.

“I haven’t heard of problems beyond fluorosis, but that’s a valid concern. There are some kids getting too much fluoride,” says Nancy Rosenzweig, vice president of corporate communication and market development at Tom’s of Maine, which in 1975 introduced the first “natural” toothpaste on the market.

“That’s why Tom Chappell started making toothpaste. He was in his bathroom reading ingredient labels and saying ‘You know, there’s a lot of stuff in here that you really shouldn’t be putting into your mouth.’ ”

Besides its natural toothpastes that contain fluoride, the small Kennebunkport-based company makes a nonfluoride toothpaste in flavors including “cinnamint” and “fennel.” When Tom’s recently began marketing its new line of natural toothpaste for children, it left out the synthetic sweeteners, neon colors and bubble gum flavors. But the toothpastes, called Silly Strawberry and Outrageous Orange, contain the same levels of fluoride as competitors’ toothpastes.

“It is always kind of a trade-off,” explains Rosenzweig. “We made a decision to have only fluoride toothpaste for children because that has been proven to be the overall benefit of toothpaste for children. We feel the benefit outweighs the negative.”

As for natural fruit flavorings being more attractive to a child’s taste buds than mint-flavored adult toothpastes, Rosenzweig says Tom’s chose wholesome flavors that would lure children to brushing. “You have to get the education across to your kids that you don’t suck the toothpaste down, just as you have to work with your kids to brush their teeth,” she says. “The alternative is they don’t brush. I guess we don’t feel like the risk factor is that high to make that trade-off.”

In fact, many in the toothpaste industry feel the new FDA warnings may be overstating the risks.

“Our position was that they went a little too far,” says Clifford Whall, director of product evaluations on the ADA’s Council on Scientific Affairs. “There wasn’t really a need for the cautionary statement about the danger of poisoning if you’ve ingested too much.

“If children were to sit around the bathroom eating toothpaste, which younger children could do, there is not enough fluoride in the toothpaste to cause them any acute harm. That just doesn’t happen. . . . If you tried to eat a lot of toothpaste, you’d throw it up.”

While Whall concedes that poison control centers do receive reports of fluoride “poisonings” every year, he says the ADA isn’t aware of any of those cases resulting in adverse effects. “It just hasn’t proven to be that kind of a problem. . . . We didn’t think you needed a label like that because it could unnecessarily scare consumers into not using toothpaste.”